Uterine Fibroids, With Unexplained Infertility Clinical Trial
Official title:
A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy
| NCT number | NCT00730886 |
| Other study ID # | UF023 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2008 |
| Est. completion date | October 6, 2011 |
| Verified date | August 2018 |
| Source | InSightec |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000
system for enhancement of fertility in women with non-hysteroscopically resectable uterine
fibroids, who are diagnosed with unexplained infertility.
Uterine fibroids are fairly common in women of child-bearing age. An evidence based review
supported removing fibroids that distort the uterine cavity to increase pregnancy rates and
decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is
minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall
require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks
including, but not limited to, infection, blood loss and postoperative uterine adhesions.
ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in
patients seeking pregnancy is considered experimental. Accumulated evidence suggests there
are no significant complications from the procedure in women seeking pregnancy as with
existing fibroid therapies; however, these data are based on a small number of patients. This
study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in
women with unexplained infertility and who have non-hysteroscopically resectable uterine
fibroids.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | October 6, 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years to 40 Years |
| Eligibility |
Inclusion Criteria: Female Partner 1. Able and willing to give consent 2. Able to attend all study visits. 3. At least one fibroid 3.0 cm or larger which is type 2 submucosal or intramural touching or abutting the cavity. 4. Able to communicate sensations during the ExAblate procedure. 5. Uterine fibroids, which are device accessible 6. Fibroids(s) clearly visible on non-contrast MRI. and with uniform enhancement with gadolinium 7. Age 21 to 40 (patients cannot be treated following their 41st birthday) 8. Patients with uterine cavitary distortion based on MRI images or ultrasound. 9. Premenopausal status 10. Normal pap smear and/or HPV testing within institutional guidelines 11. At least one ovary and at least one ipsilateral patent fallopian tube confirmed b hysterosalpingogram or laparoscopy. 12. Normal serum follicle-stimulating hormone and thyrotropin values on days 1-5 of the cycle 13. Length of 2 of the 3 most recent menstrual cycles between 24 and 35 days. 14. History of trying for pregnancy for at least 6 months 15. Documentation of ovulation using urine LH testing, serum LH testing, serum progesterone > 4 ng/dl or endometrial biopsy showing secretory endometrium in a cycle between 24 and 35 days 16. Patient needs to demonstrate that she has already undergone testing and counseling in a fertility clinic or other medical office. Male partner inclusion criteria 1. Age of male partner < 55 2. At least 10 million total mobile sperm on semen analysis within last 6 months 3. Use of donor sperm which includes at least 10 million total mobile sperm, for female candidates who otherwise meet eligibility criteria (e.g., single women, etc) Exclusion Criteria: 1. Uterine size > 16 weeks 2. Prior surgical intervention for fibroids (including UAE) except uncomplicated myomectomy (hysteroscopic, laparoscopic or abdominal) and MRgFUS. 3. Prior use of in vitro fertilization or other assisted reproductive technology 4. Previous treatment with gonadotropins or intrauterine inseminations 5. History of tubal surgery 6. History of oophorectomy 7. History of chemotherapy or radiation to the abdomen or pelvis 8. MRI showing only adenomyosis 9. Metallic implants that are incompatible with MRI 10. Severe claustrophobia that would prevent completion of procedure in MR unit 11. Patients with a BMI greater than 38. 12. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) including severe kidney disease 13. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 14. Active pelvic inflammatory disease (PID) 15. Active local or systemic infection 16. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia 17. Dermoid cyst of the ovary anywhere in the treatment path 18. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) 19. Undiagnosed vaginal bleeding 20. Patients having a contraindication to pregnancy. 21. Patients having a contraindication to surgery, including surgical myomectomy 22. Patients with type 0 submucosal fibroids. 23. More than 4 clinically significant fibroids >2cm in mean diameters 24. Patients on dialysis. 25. Hematocrit < 25 26. Hemolytic anemia 27. Patients with unstable cardiac status including: 28. Unstable angina pectoris on medication 29. Patients with documented myocardial infarction within six months of protocol entry 30. Congestive heart failure requiring medication (other than diuretic) 31. Patients on anti-arrhythmic drugs 32. Severe hypertension (diastolic BP > 100 on medication) 33. Patients with cardiac pacemakers 34. Patients planning to use adjuvant therapies post (ExAblate or Myomectomy) procedures to improve the chance of conception within 9 months of study treatment will be excluded from study (note: candidates relying on donor sperm and artificial insemination to conceive between months 3 and 9 post-treatment are allowed to participate, provided they meet all eligibility criteria) 35. Patients without uterine cavity distortion. Male partner exclusion criteria 1. Prior use of in vitro fertilization of other assisted reproductive technology 2. Previous treatment intrauterine inseminations 3. History of chemotherapy or radiation to the abdomen or pelvis 4. History of vasovasectomy 5. History of varicocelectomy 6. History of pelvic-node dissection 7. Use of calcium-channel blocking medications |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Duke University | Durham | North Carolina |
| United States | UCLA | Los Angeles | California |
| United States | Willowbend Health and Wellness | Plano | Texas |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Atlanta Interventional Institute | Smyrna | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| InSightec |
United States,
Hanstede MM, Tempany CM, Stewart EA. Focused ultrasound surgery of intramural leiomyomas may facilitate fertility: a case report. Fertil Steril. 2007 Aug;88(2):497.e5-7. Epub 2007 Feb 8. — View Citation
Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA; MRgFUS Study Group. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril. 2010 Jan;93(1):199-209. doi: 10.1016/j.fertnstert.2008.10.001. Epub 2008 Nov 14. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Live Birth Rate | Between the 3 and 9-month post-treatment visits | ||
| Secondary | Pregnancy Rate | Between the 3 and 15-month post-treatment visits | ||
| Secondary | Term Delivery Rate | Between the 3 and 15-month post-treatment visits | ||
| Secondary | Miscarriage Rate | Between the 3 and 15-month post-treatment visits | ||
| Secondary | Time to Conception | Post-treatment | ||
| Secondary | C-Section Rate | Post-treatment | ||
| Secondary | Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) | Post-treatment | ||
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | Post-treatment | ||
| Secondary | Medical Outcomes Study 36-Item Short Form Survey | Post-treatment | ||
| Secondary | Health Care Costs | Post-treatment |